Wegovy, Merck, Gameto and Neurocrine

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Good morning. I hope everyone had a restful Memorial Day weekend. I myself was doing what my editor calls one of life’s greatest joys: packing up all my belongings, traveling two miles, and then unpacking all my belongings.

Let’s dive into the news of the day.

The must-know this morning

The FDA’s new guidelines could streamline gene therapy approvals

From STAT’s Jason Mast: The FDA released draft guideline yesterday, companies could apply for a new “platform designation,” as part of a broader effort to update the agency’s approach to drugs made with new genetic technologies.

The guidance is useful in areas where multiple therapies can be delivered with a single backbone technology. For example, companies can treat different genetic conditions by supplying different genes in the same engineered virus. A platform designation would make it easier for a company to take data it used to get a first gene therapy approved — such as manufacturing analytics, inspections or certain animal safety studies — and reuse that data to get the next drug approved to get. instead of redoing everything from scratch.

In addition to viral gene therapy, the FDA notes that it could apply the designation to platforms that use antibodies, siRNA (such as Alnylam’s drugs), and lipid nanoparticles, the fat bubbles used to deliver mRNA for Covid vaccines and which are now are applied in gene therapy. editing and other medicines against rare diseases. The new designation is one of several programs that FDA biologics chief Peter Marks has proposed to speed the development of new drugs, especially for very rare diseases.

Wegovy linked to a lower risk of alcohol use disorders in real-world research

A new observational study in Nature Communications found that Wegovy was associated with a 50% and 56% lower risk of incidence and recurrence of alcohol use disorders over one year compared to other obesity medications. Its sister drug Ozempic was associated with a 44% and 39% lower risk of incidence and recurrence compared to other diabetes treatments.

The researchers behind this study, including Nora Volkow (director of the National Institute on Drug Abuse), previously found similar trends when looking at cannabis use disorder.

There are anecdotes that GLP-1 drugs such as Ozempic and Wegovy reduce cravings not only for food, but also for substances such as alcohol and tobacco. But so far, no pharmaceutical company is conducting a randomized trial to specifically test GLP-1s in addiction. The closest type of study is a Novo Nordisk study on alcohol-related liver diseases, testing alcohol intake as a secondary outcome.

Volkow said at a STAT event earlier this year that the first data on GLP-1s in addiction are “very, very exciting,” and she lamented the lack of research from pharmaceutical companies in this area.

The GLP-1 revolution is leaving Black Americans behind

While GLP-1 drugs like Ozempic and Wegovy are transforming the treatment of diabetes and obesity (and potentially many other conditions, as shown above), many Black Americans worry that their community, which already experiences a greater burden of chronic disease, is being left behind . .

Recent studies have found that black people with diabetes are less likely to be prescribed GLP-1 medications. They also experience significant insurance and access barriers, and the public’s obsession with the drugs is a further reminder of how black bodies are policed ​​and judged by society.

STAT partnered with Word In Black, a network of 10 Black news publishers, to report this story. Read more from Word In Black’s Anissa Durham here and also check out the accompanying article with a photo essay and first-person accounts of how Black Americans feel about their weight and the pressure to lose weight in this new Ozempic era.

Investors are pouring money into fertility-oriented biotechnology

Gameto, a biotech company looking to improve IVF, said today it has raised $33 million in a Series B round led by Two Sigma Ventures and RA Capital.

IVF involves removing eggs from a woman’s body and fertilizing them, but often the eggs removed are not mature enough and must be discarded. The idea behind Gameto’s main product, Fertilo, is in vitro maturation (IVM) that can increase the chance of success with IVF. Fertilo is a solution that contains “ovarian support cells” that are intended to help mature the eggs that are removed from the body.

Fertilo is already in clinical use in Australia and Latin America, and in the US, Gameto has preliminary approval to begin Phase 3 trials upon completion of certain testing and manufacturing requirements.

For more background on this startup, check out our story from last year.

Neurocrine appoints new CEO as it looks to a new phase of growth

Neurocrine said yesterday that its founding CEO, Kevin Gorman, is retiring, and Kyle Gano, currently the Chief Business Development and Strategy Officer, will succeed him.

Stifel analyst Paul Matteis wrote that this feels like “somewhat a natural transition point for the company” as its approved drug for tardive dyskinesia, Ingrezza, is well established, and as it moves into a new phase of growth with the expected launch of a congenital medicine . adrenal hyperplasia drug and with several drugs in the pipeline.

Read more

• Health insurers brag to investors about the use of AI, but prefer not to talk about it, STAT
• Heat waves associated with increased risk of preterm birth in the US, STAT
• After fourteen years as a partner at Genentech/Roche, James Sabry returns to the biotech fray. Endpoints
• This Mississippi hospital transfers some patients to prison while awaiting mental health treatment. ProPublica